Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Cadwell ApneaTrak Pediatric Effort Belt Kit: 2 sensors, 2 ea-15",25",35" Straps
DYMEDIX DIAGNOSTICS, INC.
18-12230-0302
In Commercial Distribution

  • 00817377021534 ()


  • Polysomnograph
Perfect Fit™ II R/S Pediatric Kit includes: 2- Perfect Fit™II R/S sensors, 2-15” Effort Belt Strap, 2-25” Effort Belt Strap, and 2-35” Effort Belt Strap and 2- R/S Interface Cable, Alice 6
DYMEDIX DIAGNOSTICS, INC.
18-12216-0302
In Commercial Distribution

  • 00817377021527 ()


  • Polysomnograph
Perfect Fit™ II R/S Pediatric Kit includes: 2- Perfect Fit™II R/S sensors, 2-15” Effort Belt Strap, 2-25” Effort Belt Strap, and 2-35” Effort Belt Strap and 2- R/S Interface Cable, Grael
DYMEDIX DIAGNOSTICS, INC.
18-12215-0302
In Commercial Distribution

  • 00817377021510 ()


  • Polysomnograph
Perfect Fit™ II R/S Pediatric Kit includes: 2- Perfect Fit™II R/S sensors, 2-15” Effort Belt Strap, 2-25” Effort Belt Strap, and 2-35” Effort Belt Strap and 2- R/S Interface Cable, Embla
DYMEDIX DIAGNOSTICS, INC.
18-12213-0302
In Commercial Distribution

  • 00817377021497 ()


  • Polysomnograph
Perfect Fit™II R/S Interface Module Cable, Chest, Keyhole
DYMEDIX DIAGNOSTICS, INC.
12-42001-0001
In Commercial Distribution

  • 00817377021299 ()


  • Polysomnograph
Perfect Fit™II R/S Interface Module Cable, Abdomen, Keyhole
DYMEDIX DIAGNOSTICS, INC.
12-42000-0001
In Commercial Distribution

  • 00817377021282 ()


  • Polysomnograph
Perfect Fit Effort Belt, Interface Cable, Pediatric
DYMEDIX DIAGNOSTICS, INC.
12-41213-0301
In Commercial Distribution

  • 00817377021275 ()


  • Polysomnograph
Perfect Fit Effort Belt, Interface Cable, Adult
DYMEDIX DIAGNOSTICS, INC.
12-41213-0001
In Commercial Distribution

  • 00817377021268 ()


  • Polysomnograph
Perfect Fit Effort Belt, Interface Cable, Alice 5, Pediatric
DYMEDIX DIAGNOSTICS, INC.
12-41203-0301
In Commercial Distribution

  • 00817377021251 ()


  • Polysomnograph
Perfect Fit™ 3D Effort Belt Sensor, Chest, Embla
DYMEDIX DIAGNOSTICS, INC.
11-45002-0002
In Commercial Distribution

  • 00817377020728 ()


  • Polysomnograph
Perfect Fit™ 3D Effort Belt Sensor, Chest, Alice 5
DYMEDIX DIAGNOSTICS, INC.
11-45001-0002
In Commercial Distribution

  • 00817377020704 ()


  • Polysomnograph
Perfect Fit II Effort Belt Strap, XXL, 75", 2 Pk
DYMEDIX DIAGNOSTICS, INC.
11-43300-7502
In Commercial Distribution

  • 00817377020667 ()


  • Polysomnograph
Perfect Fit II Effort Belt Strap, Large, 45"
DYMEDIX DIAGNOSTICS, INC.
11-43300-4501
In Commercial Distribution

  • 00817377020636 ()


  • Polysomnograph
Cadwell ApneaTrak Effort Belt Strap, XXL, 75", 2 Pack
DYMEDIX DIAGNOSTICS, INC.
11-43200-7502
In Commercial Distribution

  • 00817377020612 ()


  • Polysomnograph
Cadwell ApneaTrak Effort Belt Strap, Large, 45", 2 Pack
DYMEDIX DIAGNOSTICS, INC.
11-43200-4502
In Commercial Distribution

  • 00817377020599 ()


  • Polysomnograph
Perfect Fit™Effort Belt Strap, Large 45", 2 pack
DYMEDIX DIAGNOSTICS, INC.
11-43100-4502
In Commercial Distribution

  • 00817377020544 ()


  • Polysomnograph
Perfect Fit™Effort Belt Strap, Medium, 30", 2 Pack
DYMEDIX DIAGNOSTICS, INC.
11-43100-3002
In Commercial Distribution

  • 00817377020520 ()


  • Polysomnograph
Perfect Fit Adult Effort Belt Sensors, (1-Chest, 1-Abdomen)
DYMEDIX DIAGNOSTICS, INC.
11-42900-0602
In Commercial Distribution

  • 00817377020513 ()


  • Polysomnograph
Cadwell ApneaTrak Adult Effort Belt Sensor, Chest
DYMEDIX DIAGNOSTICS, INC.
11-42700-0601
In Commercial Distribution

  • 00817377020490 ()


  • Polysomnograph
Perfect Fit ™II Adult Effort Belt Sensor, Abdomen, Alice 3
DYMEDIX DIAGNOSTICS, INC.
11-42405-0601
In Commercial Distribution

  • 00817377020476 ()


  • Polysomnograph
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